Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
dietary, nutrition, fatigue, quality of life
Brief summary
The overarching goal of this project is to critically evaluate the efficacy of incorporating dietary guidance within multiple sclerosis (MS) care for improving long-term quality of life (QoL) compared to usual care. The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS QoL compared to usual care control (Dietary Guidelines for America), and the secondary objectives and the long-term effects on, motor function, low-contrast vision sensitivity, fatigue, mood, and disease activity assessed by brain imaging.
Detailed description
In the United States, MS affects nearly 1 million people with a 2.8:1 female to male ratio and the highest incidence rates among whites and African Americans. The economic cost of managing MS is substantial. In the U.S., the total medical costs for patients with MS increased from $116 million in 2002 to $198 million in 2013. MS is a chronic, neuroinflammatory, and neurodegenerative disease-causing symptoms of pain, fatigue, and changes in vision, cognition, and movement that greatly reduce quality of life (QoL) and the ability to maintain employment. The overarching goal of this project is to critically evaluate the efficacy of incorporating dietary guidance within multiple sclerosis (MS) care for improving long-term quality of life (QoL) compared to usual care. The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS QoL compared to usual care control (Dietary Guidelines for America), and the secondary objectives and the long-term effects on, motor function, low-contrast vision sensitivity, fatigue, mood, and disease activity assessed by brain imaging. The proposed study will consist of study participants attending 3 in-person site visits, months 0, 3, and 24, and online surveys every 3 months (months 0-24). This study will use a randomized single-blind controlled design to test the short-term (6 months) and long-term (an additional 18 months) impact of the intervention diets on symptoms of MS including QoL and related outcomes stated above. We will use a fourteen-day run-in period to identify participants who are most likely to be successful in completing study procedures; this process has been effective in our previous studies. Participants who successfully complete all baseline self-reported outcomes and follow all study procedures during the seven-day run-in period will be scheduled for an on-site baseline visit for randomization to one of three diets (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination and Dietary Guidelines for America). On-site study visits will include blood draws, motor, cognitive, vision function assessments, and MRI. Motor assessments will include a 6-minute walk test, 25-foot walk test, 9-hole pegboard to test hand function, symbol digit exercise to test thinking functions, and critical flicker fusion test, ocular coherence tomography and low contrast vision sensitivity to test vision. The study participant will be escorted to the MRI unit to complete a non-contrast MRI of the brain. At the baseline visit, participants will be randomized. Participants assigned to the intervention diets will be given intervention specific educational materials including shopping lists, example menus and recipes, and the study supplements. Study participants randomized to the dietary guidelines for Americans diet will receive emails and/or text messages (approximately 3-6 weeks) to receive resources with websites for the Dietary Guidelines of America, and recent multiple sclerosis-related research that does not involve diet. Study team will provide fish oil, essential fatty acids, and phosphatidylcholine to the two intervention groups only. The participant will be scheduled for a Zoom video conference meeting with the assigned registered dietitian to review the assigned study diet. In addition, subjects will collect saliva specimens for microbiome analysis at each of the 3 site study visits (months 0, 3 and 24). Dietary History Questionnaire III will be completed at months 0, 3, 12 and 24 and will be used to assess adherence to the assigned dietary pattern. The online questionnaires sent to participants every 3 months will also be used to track supplement intake, medication use, and details about health & life events, MS symptoms, fatigue, quality of life, doctor's appointment, and side effects they may be experiencing.
Interventions
DIETARY_SUPPLEMENTBodyBio Balance Oil
nutraceutical supplement
DIETARY_SUPPLEMENTKirunal Fish Oil
nutraceutical supplement
DIETARY_SUPPLEMENTBodyBio PC
nutraceutical supplement
BEHAVIORALModified Paleolithic Elimination diet
1. Complete elimination of all gluten-, dairy-, and egg-containing foods. 2. Increase fruit and vegetable intake to 6-9 servings/day comprising of 2-3 servings each of the following categories: intensely colored, sulfur-rich, and leafy greens. 3. Consume 6-12 ounces/day protein including organ meats and fatty fish. 4. Consume fermented foods daily. 5. Consume daily servings of algae, seaweed, and nutritional yeast.
BEHAVIORALTime Restricted Olive Oil Based (TROO) Ketogenic Diet
1. Restriction of dietary carbohydrates to \< 50 grams/day. 2. Use olive oil (cold-pressed extra virgin preferred) to increase fat intake to \>160 grams/day. 3. Consume \<100 grams/day protein. 4. Limit dairy to 2 servings/day of whole fat options (completely exclude reduced fat dairy). 5. Consume at least 3 servings/day non-starchy vegetables.
BEHAVIORALUsual diet with Dietary Guidelines for Americans Diet information
1. Limit sodium to \< 2,300 mg/day. 2. Limit added sugar and saturated fat intake to \<10% of kcal/day, respectively. 3. Consume 5 servings of fruits and vegetables per day. 4. Consume 6-9 ounce equivalents/day of grains, making at least half whole grain options. 5. Consume 3 servings of reduced fat dairy per day. 6. Consume 6 ounces/day protein foods.
Sponsors
Terry L. Wahls
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Assessors and principle investigator masked
Intervention model description
Randomized controlled study design
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Eligibility for the run-in phase of the study: Participants will be eligible to enroll in the fourteen-day run-in phase of the study if they meet the following inclusion and
Exclusion criteria
INCLUSION CRITERIA: * A definitive diagnosis of RRMS based on the 2017 revised McDonald Criteria. * The ability to prepare, or availability of someone to prepare, home-cooked meals. * Must own a computer, smartphone, or tablet device that has internet access to complete online surveys and capable of running study related applications. * Must be willing to follow study procedures outlined and explained to them. * Be between the ages of 18 to 70 at the time of consent. * Must be able to walk 25 feet without support. * Willingness to be randomized and follow any of the study diets. * Must consent to sharing the clinical notes from their primary care and neurology providers during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) | baseline to 3 Months | Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. |
| Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) | baseline to 3 Months | Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale score (FSS) | Baseline to 3 months | Change in FSS survey question mean scores, scores range from 1-7, lower is better. |
| Brain volume as measured by non contrast magnetic resonance imaging (MRI) | baseline to 24 months | Change in MRI grey matter brain volume, more is better |
| Brain lesions as measured by non contrast magnetic resonance imaging (MRI) | baseline to 24 months | Change in inflammatory lesions numbers as measured by non contrast brain MRI, fewer is better |
| Timed 25 foot walk test | baseline to 3 months | seconds required to walk 25 feet, lower is better |
| 9 Hole peg board test | baseline to 3 months | seconds require to move 9 pegs to various locations on a peg board, fewer seconds is better |
| Modified Fatigue Impact Scale (MFIS) | baseline to 3 months | Change in MFIS survey questions, scores range from 0-84, lower score is better. |
| Dietary History Questionnaire IIi | baseline to 12 months | Change in dietary intake measured by survey questions |
| Critical flicker fusion | baseline to 3 months | change in The herz at which a flickering light is seen as non-flickering as measured by herz |
| Ocular Coherence tomography | baseline | Measure of optic nerve and retina depths using infrared light technology |
| Neurofilament light chain | baseline to 3 months | blood biomarker of neuroaxonal (brain) damage |
| Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) | baseline to 12 Months | Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. |
| Low contrast visual acuity | baseline to 3 months | A measure of best corrected vision, measure is log minimal angle of resolution at 2.5% contrast. Lower number is better. |
| Hospital Anxiety Depression Scale (HADS) | baseline to 3 months | Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence |
Countries
United States
Outcome results
None listed